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Phosphodiesterase Inhibitor

Nebulized Inhaled Milrinone in a Hospitalized Advanced Heart Failure Population (iMilrinone Trial)

Phase 1
Waitlist Available
Led By Zubair Shah, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up plasma samples will be drawn around the 4th inhaled dose and after the dose at the following time point of 8 hours to assess for serum milirinone concentration fro the trough to be no less than 50ng/ml and the peak to be no greater than 500ng/ml.
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing inhaled milrinone for patients with severe heart failure. The goal is to see if inhaling the medication can reduce side effects and avoid the need for continuous IV lines. Milrinone helps the heart pump more effectively, which can improve symptoms.

Eligible Conditions
  • Congestive Heart Failure
  • Heart Failure
  • Cardiomyopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~plasma samples will be drawn around the 4th inhaled dose and after the dose at the following time point of 8 hours to assess for serum milirinone concentration fro the trough to be no less than 50ng/ml and the peak to be no greater than 500ng/ml.
This trial's timeline: 3 weeks for screening, Varies for treatment, and plasma samples will be drawn around the 4th inhaled dose and after the dose at the following time point of 8 hours to assess for serum milirinone concentration fro the trough to be no less than 50ng/ml and the peak to be no greater than 500ng/ml. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pharmacokinetic analysis
Safety Analysis
Secondary study objectives
All cause mortality
Other study objectives
Study Withdrawal Criteria -1
Withdrawal criteria - 2
Withdrawal criteria - 3
+4 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Inhaled nebulized milrinoneExperimental Treatment1 Intervention
Inhaled nebulized milrinone 60mg/4ml every 8 hours using a jet nebulizer
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Milrinone
FDA approved

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
512 Previous Clinical Trials
176,723 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
904 Previous Clinical Trials
934,069 Total Patients Enrolled
Zubair Shah, MDPrincipal InvestigatorUniversity of Kansas
Nicholas Haglund, MDPrincipal Investigator - University of Kansas
University of Kansas Hospital
St George'S University (Medical School)
Maine Medical Center (Residency)
Zachary L Cox, PharmDPrincipal InvestigatorVanderbilt University Medical Center/ Lipscomb University College of Pharmacy
1 Previous Clinical Trials
60 Total Patients Enrolled
~2 spots leftby Dec 2025
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